Clinical QA Specialist

About the role

At Hologic, we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you’ll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting.

Responsibilities

• Independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps.
• Interact with internal teams, sales personnel, customers, patients, and regulatory agencies to communicate and respond effectively.
• Ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions.
• Support and lead investigations, including CAPAs, nonconformances, and other quality system processes.
• Develop metrics and quality reports related to reportable events and identify potential excursions.
• Innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements.
• Participate in and lead internal and external audits, inspections, and assessments.

Requirements

• Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management.
• Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic’s product portfolio.
• Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments.
• Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications.

Skills

• Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps.
• Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies.
• Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions.
• Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes.
• Experience in developing metrics and quality reports related to reportable events and identifying potential excursions.
• Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements.
• Proficient in leading or participating in internal and external audits, inspections, and assessments.

Behaviors

• Proactive and detail-oriented, ensuring compliance with regulatory requirements and internal procedures.
• Collaborative and team-oriented, fostering strong relationships across functions to support investigations and reporting activities.
• Customer-focused, ensuring communications and responses are timely, accurate, and aligned with patient safety goals.
• Resilient and adaptable, thriving in a fast-paced and evolving environment.
• Problem-solving mindset, with a commitment to driving resolution and continuous improvement in quality processes.

Experience

• Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field. Risk Managers will also be considered.
• 5+ years of experience in a similar role, preferably within the medical device or healthcare industry.
• Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments.
• Proven track record in supporting or leading CAPAs, nonconformances, and quality investigations.

Pay

The annualized base salary range for this role is $85,200 - $133,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Schedule

N/A

Benefits

N/A

Agency and Third-Party Recruiter Notice

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.